Details for New Drug Application (NDA): 021324
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The generic ingredient in ENTOCORT EC is budesonide. There are twenty-two drug master file entries for this compound. Forty-three suppliers are listed for this compound. Additional details are available on the budesonide profile page.
Summary for 021324
Tradename: | ENTOCORT EC |
Applicant: | Padagis Us |
Ingredient: | budesonide |
Patents: | 0 |
Pharmacology for NDA: 021324
Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 021324
Suppliers and Packaging for NDA: 021324
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ENTOCORT EC | budesonide | CAPSULE, DELAYED RELEASE;ORAL | 021324 | NDA | Padagis US LLC | 0574-9855 | 0574-9855-10 | 1 BOTTLE in 1 CARTON (0574-9855-10) / 100 CAPSULE in 1 BOTTLE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, DELAYED RELEASE;ORAL | Strength | 3MG | ||||
Approval Date: | Oct 2, 2001 | TE: | AB | RLD: | Yes |
Expired US Patents for NDA 021324
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Padagis Us | ENTOCORT EC | budesonide | CAPSULE, DELAYED RELEASE;ORAL | 021324-001 | Oct 2, 2001 | ⤷ Sign Up | ⤷ Sign Up |
Padagis Us | ENTOCORT EC | budesonide | CAPSULE, DELAYED RELEASE;ORAL | 021324-001 | Oct 2, 2001 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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